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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MICRO THERAPEUTICS, INC. DBA EV3 PIPELINE FLEX W/SHIELD TECHNOLOGY INTRACRANIAL ANEURYSM FLOW DIVERTER

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MICRO THERAPEUTICS, INC. DBA EV3 PIPELINE FLEX W/SHIELD TECHNOLOGY INTRACRANIAL ANEURYSM FLOW DIVERTER Back to Search Results
Model Number PED2-475-20
Device Problems Unintended Movement (3026); Activation Failure (3270); Physical Resistance/Sticking (4012)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 06/20/2022
Event Type  malfunction  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Medtronic received a report that the pipeline was unable to be resheathed and did not open. The patient was undergoing treatment for an unruptured aneurysm located in the right paraclinoid ica aneurysm, which was noted to be off-label. The patient's vessel tortuosity was normal. It was reported that there was a resheathing issue with the pipeline. The tip of the pipeline braid was stuck between the microcatheter and was not opening up. The doctor flipped the ptfe sleeves and at first the braid opened pretty well, but when they tried to drag and drop and again open it after resheathing, the braid was stuck and was not able to advance. It was noted that there was severe friction/difficulty during delivery/positioning, and movement during deployment. The pipeline did not miss the landing zone, and did not jump during deployment. The pipeline was placed at least 3mm past the aneurysm neck on each side. The side branches were not covered by the pipeline, and the tip of the catheter had moved during deployment. The pipeline was replaced, which was implanted at the intended location.  the patient did not experience any injury or complications. The devices were prepared according to the instructions for use (ifu). Ancillary devices include an 8f rightfemoral sheath, phenom plus guide catheter, phenom 27 microcatheter, and synchro 2 guidewire.
 
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Brand NamePIPELINE FLEX W/SHIELD TECHNOLOGY
Type of DeviceINTRACRANIAL ANEURYSM FLOW DIVERTER
Manufacturer (Section D)
MICRO THERAPEUTICS, INC. DBA EV3
9775 toledo way
irvine CA 92618
Manufacturer (Section G)
MICRO THERAPEUTICS, INC. DBA EV3
9775 toledo way
irvine CA 92618
Manufacturer Contact
glen belmer
9775 toledo way
irvine, CA 92618
6122713209
MDR Report Key14830795
MDR Text Key295065116
Report Number2029214-2022-01065
Device Sequence Number1
Product Code OUT
UDI-Device Identifier00763000284633
UDI-Public00763000284633
Combination Product (y/n)N
Reporter Country CodeCA
PMA/PMN Number
P100018
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 07/24/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/27/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberPED2-475-20
Device Catalogue NumberPED2-475-20
Device Lot NumberB113087
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received06/28/2022
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured11/05/2020
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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